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Antihemophilic Factor (Human or Recombinant) |
Advate; AHF (Human); AHG; Alphanate; Factor VIII; Hemofil M; Humate-P; Koate DVI; Koate-HP; Kogenate FS; Monarc-M; Monoclate-P; Profilate HP; ReFacto |
Clinical Trial: Use of NovoSeven® in Cardiac Surgery
This study is currently recruiting patients.
Verified by Novo Nordisk September 2005
|
Purpose
This trial is conducted in Europe.
The trial is planned to investigate the safety and efficacy of NovoSeven® in the management of post-operative bleeding in patients following cardiac surgery.
| Condition | Intervention | Phase |
|---|---|---|
| Post-operative bleeding following cardiac surgery | Drug: Activated recombinant human factor VII (NovoSeven®) | Phase II |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Bleeding in Patients Following Cardiac Surgery.
Further Study Details:
Primary Outcomes: Incidence of critical, serious adverse events within 30 days.
Secondary Outcomes: Amount of transfusions; Surgical drainage volume
Expected Total Enrollment: 210
Secondary Outcomes: Amount of transfusions; Surgical drainage volume
Expected Total Enrollment: 210
Study start: October 2004
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Post-operative bleeding according to pre-defined criteria for critical bleeding.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00154427
Public Access to Clinical Trials - Novo Nordisk. Please contact NN via email: clinicaltrials@novonordisk.com
Denmark
Rigshospitalet, Hjertecentret, Copenhagen, Denmark; Recruiting
France
Hospital Laennec, Nantes, France; Recruiting
Germany
Klinik für Anästhesie und Operative Intensivmedizin, Berlin, Germany; Recruiting
Italy
Policlinico San Donato, San Donato Milanese, Italy; Recruiting
Spain
Hospital Ramon y Cajal, Madrid, Spain; Recruiting
Sweden
Lund University Hospital, Lund, Sweden; Recruiting
United Kingdom
Southampton General Hospital, Southampton, United Kingdom; Recruiting
Study chairs or principal investigators
Mark Dowling, Study Director, Novo Nordisk Limited
More Information
Study ID Numbers: F7CARD-1610; Eudract No. 2004-000100-40
Last Updated: September 9, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00154427
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; Sweden: Medical Products Agency; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Denmark: Danish Medicines Agency; Germany: Paul-Ehrlich-Institut
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 9, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00154427
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Spanish Agency of Medicines; France: Afssaps - French Health Products Safety Agency; Sweden: Medical Products Agency; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Denmark: Danish Medicines Agency; Germany: Paul-Ehrlich-Institut
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Advate (Drug Digest)
- AHF (Human) (Drug Digest)
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